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NCT04035486 · OUTCOME

Concordance of Epidermal Growth Factor Receptor (EGFR) Mutation Status Between the Local EGFR Mutation Test and the Central Cobas® EGFR Mutation Test v2 Results: L858R (Randomized Component)

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) · Source last updated 2026-09-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Screening/Baseline

What was measured

Comparing the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results in participants with L858R, excluding invalid results. Since this endpoint uses pre-randomization data to compare results from a central vs. local lab, randomized component treatment arms were combined for analysis.

Analysis population: Participants with a valid local and central test result.

Groups in this outcome

Overall Randomized Participants

All subjects from both randomized treatment arms: AZD9291 + Chemo and AZD9291

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Overall Randomized Participants247

Reported measurements

Local Laboratory Test = Negative, Cobas Central Test = Negative
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Randomized Participants145Not reportedNot reportedNot reportedNot reported
Local Laboratory Test = Negative, Cobas Central Test = Positive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Randomized Participants0Not reportedNot reportedNot reportedNot reported
Local Laboratory Test = Positive, Cobas Central Test = Negative
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Randomized Participants6Not reportedNot reportedNot reportedNot reported
Local Laboratory Test = Positive, Cobas Central Test = Positive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Randomized Participants96Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        145
    title
    Local Laboratory Test = Negative, Cobas Central Test = Negative
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Local Laboratory Test = Negative, Cobas Central Test = Positive
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Local Laboratory Test = Positive, Cobas Central Test = Negative
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        96
    title
    Local Laboratory Test = Positive, Cobas Central Test = Positive
denoms
  1. counts
    1. group Id
      OG000
      value
      247
    units
    Participants
description
Comparing the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results in participants with L858R, excluding invalid results. Since this endpoint uses pre-randomization data to compare results from a central vs. local lab, randomized component treatment arms were combined for analysis.
groups
  1. description
    All subjects from both randomized treatment arms: AZD9291 + Chemo and AZD9291
    id
    OG000
    title
    Overall Randomized Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants with a valid local and central test result.
reporting Status
POSTED
time Frame
Screening/Baseline
title
Concordance of Epidermal Growth Factor Receptor (EGFR) Mutation Status Between the Local EGFR Mutation Test and the Central Cobas® EGFR Mutation Test v2 Results: L858R (Randomized Component)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice